Medical Procedure Patents Not Enforceable

Here’s the situation: You’re a physician who has developed a ground-breaking new procedure for providing treatment to your patients. You have spent years of your life and thousands of your dollars perfecting this particular technique. Your procedure doesn’t involve any new devices and you didn’t create any new pharmaceutical combination; rather, it’s the way that the treatment is rendered that nobody else has quite figured out. Could this new procedure be the subject of a patent? The short answer is yes, but as we’ll see, not every medical procedure patent is enforceable against an infringer.

A patent is a property right guaranteed by the United States Constitution in order to promote innovation. In nearly every field of human endeavor, the holder of patent rights to a particular method, process, article of manufacture or composition of matter is entitled, for a limited time, to maintain exclusive control over who can practice, manufacture or otherwise profit from the invention as disclosed in the patent. So as not to stifle creativity and invention, patent rights generally only last for twenty years from the date of the initial filing of the application.

In order to enforce one’s patent rights against infringers who don’t seem to respond to cease and desist letters, the patent-holder must file a lawsuit. However, that patents on medical procedures are a special case. While an applicant may be able to obtain a patent on a particular medical procedure, ethical and financial considerations raised by the possibility that physicians could be sued for treating their patients in a particular manner led Congress to enact legislation disallowing the enforcement of these types of patents. Legislators were particularly concerned about an actual case where a physician was sued for making an incision of a particular shape in the process of performing cataract removal surgery.

The bottom line is that while the Patent and Trademark Office may allow a patent for a medical procedure to be issued, the law now says that the holder of any such patent issued subsequent to September 30, 1996 will not be able to bring suit to stop another physician from practicing the medical procedure taught in the patent. Clearly, however, the law is narrowly tailored to "pure" medical procedures and does not apply to medical devices, compositions of matter, or biotechnology process or product patents.

 Back